U.S. limits use of J&J’s COVID vaccine on blood clot risks -Breaking
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© Reuters. FILE PHOTO: A vial of the Johnson & Johnson’s coronavirus disease (COVID-19) vaccine is seen at Northwell Health’s South Shore University Hospital in Bay Shore, New York, U.S., March 3, 2021. REUTERS/Shannon Stapleton/File Photo(Reuters) -The U.S. health regulator said on Thursday it was limiting the use of Johnson & Johnson (NYSE:)’s COVID-19 vaccine for adults due to the risk of a rare blood clotting syndrome, the latest setback to the shot that has been eclipsed by rivals.
The J&J shot, which received U.S. clearance in February 2021 for adults, can be administered in cases where authorized or approved COVID-19 vaccines are not accessible or if an individual is less keen on using the other two shots, the Food and Drug Administration said.
J&J is one of the three vaccines in use in the United States. Other two vaccines come from Moderna (NASDAQ: Pfizer (NYSE:).
A vaccine manufacturer said that it had updated U.S.COVID-19 vaccination fact sheets to alert about the possibility of thrombosis associated with thrombocytopenia Syndrome (TTS), an uncommon but potentially deadly condition.
Use of the J&J shot has been weak in high-income countries, hurt by reports of rare, potentially deadly blood clots, production issues, including an accidental mix-up of ingredients by a contract manufacturer, and concerns about efficacy.
A glut in supply led to the drugmaker revoking its COVID-19 forecast last month.
Cases of TTS, which involves blood clots accompanied by a low level of platelets, have previously been reported in recipients of the J&J vaccine.
The FDA in January amended the fact sheet for the J&J vaccine to include the risk of immune thrombocytopenia, months after the European Union’s drugs regulator took similar action.
After reviewing the reports, the FDA determined that the TTS risk warranted the restriction of single-dose shots.
The U.S. Centers for Disease Control and Prevention in December had recommended that Americans choose to receive mRNA shots from Pfizer and Moderna over J&J’s vaccine due to the rare cases of blood clotting.
Around 18.7 million Americans have received a J&J COVID-19 shot compared with 217.5 million people who received the Moderna vaccine and 340.6 million people who received Pfizer’s shot, according to CDC.
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